QC Sampling Laboratory Implementation Lead

QC Sampling Laboratory Implementation Lead Location: Northwest Suburbs of Chicago, IL Work Arrangement: On-site Contract: 6+ months duration with potential for extensions Position Summary: Automated Systems, Inc. (ASI) is seeking an experienced QC Sampling Laboratory Implementation Lead to support the implementation and operational readiness of a new GMP Quality Control (QC) sampling laboratory at our client’s existing GMP production facility in the Northwest Suburbs of Chicago, IL. The laboratory will support Environmental Monitoring (EM), utility monitoring, in-process sampling, and other approved site sampling activities. In this role, you will develop and execute the laboratory implementation plan, establishing SOPs, work instructions, forms, logbooks, sampling workflows, and chain-of-custody controls to ensure compliant, consistent, and traceable operations. You will coordinate equipment qualification and release, analyst staffing and training requirements, qualification programs, and inventory management processes, including consumables tracking, storage controls, and replenishment systems. Working closely with QC, Quality Assurance (QA), Manufacturing, Engineering, Validation, Facilities, EHS, Procurement, IT, and external testing laboratories, you will ensure that equipment, procedures, materials, and personnel are ready before go-live. You will also lead operational readiness assessments, address implementation gaps, and coordinate the formal handover to routine operations while ensuring clear roles and responsibilities and adherence to GMP requirements. Key Responsibilities: Laboratory Implementation and Operational Readiness · Lead implementation of the QC Sampling Laboratory from project execution through operational readiness and handover. · Translate approved User Requirements Specifications into detailed implementation activities, milestones, readiness criteria, and deliverables. · Coordinate activities across QC, QA, Engineering, Validation, Facilities, Procurement, Manufacturing, EHS, and other applicable functions. · Establish controlled workflows for equipment staging, sample labeling, sample collection, interim storage, transfer, and sampling schedule coordination. Sampling Program Implementation · Establish compliant sampling workflows for Environmental Monitoring, including viable air, non-viable air, surface, and personnel monitoring as applicable to the approved scope. · Establish utility-monitoring sampling workflows for applicable systems such as Water for Injection, clean steam, and processed compressed air. · Establish approved in-process sampling workflows and associated handling, storage, and transfer requirements. Governing SOPs and Quality System Infrastructure · Author, revise, route, and implement governing SOPs, work instructions, forms, logbooks, and job aids required to operate the sampling function. · Define requirements for sample collection, labeling, handling, storage, transfer, documentation, and reconciliation. · Establish procedures for preparation, use, cleaning, storage, calibration status verification, and control of sampling equipment, as applicable. · Support deviation, change-control, and CAPA activities associated with project implementation. Equipment Qualification and Validation · Coordinate lifecycle implementation of sampling and Environmental Monitoring equipment, including user requirements, procurement, receipt, installation, qualification, release, and turnover. · Provide QC subject-matter expertise for equipment risk assessments and validation strategies. · Draft, review, manage, or support execution of qualification and validation protocols for laboratory and EM sampling equipment. Analyst Role Development and Training · Develop job descriptions for QC Sampling Analysts based on the approved sampling scope, coverage model, and required competencies. ·…

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